Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach

Part of paid clinical trials in Seattle, Washington.

Sponsor
VA Office of Research and Development
Study ID
NCT05104450
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lifestyle intervention — BEHAVIORAL
    Intervention Arm: Usual Care plus a lifestyle behavior change intervention aimed at improving eating habits and increasing physical activity. The lifestyle behavior change intervention encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.

Study Details

Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity to improve population health. OSA reduces quality of life and is associated with greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, patients with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. To meet these challenges, the investigators propose a pragmatic trial of proactively offering a remote video-based and self-directed lifestyle-based weight loss intervention with remote coaching to patients with OSA. The investigators primary aim is to test the effectiveness of a proactively delivered and pragmatic lifestyle intervention to improve co-primary endpoints of sleep-related quality of life and weight among patients with OSA and obesity. Secondarily, the investigators will compare additional outcomes between groups including cardiovascular risk scores, sleep symptoms, AHI, well-being, and global ratings of change. Finally, the investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation. The investigators will identify patients with OSA and obesity nationwide (n=696) in VA using data from the VA's Corporate Data Warehouse (CDW), and the investigators will contact potentially eligible patients. After confirming eligibility and consent, the investigators will randomly assign subjects to receive the study's lifestyle intervention or usual care alone. The study uses CDW to assess weight change. Subjects will complete questionnaires at baseline at 3, 12 and 21 months after randomization. The lifestyle intervention in POWER focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period.

Key Dates

Start date
Apr 4, 2022
Status verified
Oct 2025
Primary completion
Aug 1, 2024
Completion
May 1, 2025

Study Design

Enrollment
696 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: lifestyle intervention
    The investigators will provide participants with the behavioral lifestyle intervention in addition to usual care.
  • No Intervention: usual care control
    Participants in this arm will continue with usual care without the lifestyle intervention.

Primary Outcome Measure

Change in Sleep-related Quality of Life [ Time Frame: baseline to 12 months post randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532-

Find similar trials in Seattle, WA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
VA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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